Learn About Flowflex COVID-19 At Home Antigen Test

The FlowFlex COVID-19 antigen test is a rapid test used for the detection of SARS-CoV-2 antigens in anterior nasal specimens. Intended for self-testing use at home and available for use under an Emergency Use Authorization (EUA) only. Carefully read the instructions before performing this COVID-19 test on you or a loved one. Failure to follow the instructions may result in inaccurate test results.

ACON Laboratories, Inc. is the only legal manufacturer of the FDA EUA Flowflex COVID-19 Antigen Home Test.

This COVID-19 test product has not been FDA cleared or approved but has been authorized by FDA under an EUA.This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of IVDs for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated, or authorization is revoked sooner.

For more information on EUAs please visit: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

For the most up to date information on COVID-19, please visit: www.cdc.gov/COVID19

Flowflex COVID-19 At Home Antigen Test Overview:

• Easy-to-use nasal swab test
• Requires just 1 test
• Can be used to test children as young as 2 years old
• For use with and without COVID-19 symptoms
• Accurate results in 15 minutes
• No need to send off to a lab to obtain results
• Compact packaging for “On-The-Go” testing

FAQ's about the Flowflex COVID-19 At Home Antigen Test

1) What is the Flowflex COVID-19 Antigen Home Test?

The Flowflex COVID-19 Antigen Home Test is a rapid test for the detection of SARS-CoV-2 antigens in anterior nasal specimens. It is intended for self-testing use. For use under an Emergency Use Authorization (EUA) only.

2) How does this test work?

This test uses a nasal swab sample to determine the presence or absence of COVID-19 antigens in nasal samples. For a demonstration on how this test works, watch the instructional video.

3) What is the difference between Antigen, Molecular, and Antibody tests?

There are different kinds of tests for COVID-19. Molecular tests (also known as PCR tests) detect genetic material from the virus. Antigen tests, such as the Flowflex COVID-19 Antigen Home Test detect proteins from the virus. Antigen tests are very specific for the COVID-19 virus but are not as sensitive as molecular tests. This means that a positive result is highly accurate, but a negative result does not rule out infection. If your test result is negative, you should discuss with your healthcare provider whether an additional molecular test is necessary and if you should continue isolating at home. Another type of test is an antibody test. A COVID-19 antibody test detects antibodies that have been produced by your immune system in response to a previous COVID-19 infection or vaccination. Antibody tests are not suitable for diagnosing an active COVID-19 infection.

For more information on the different kinds of COVID-19 tests, please visit: https://www.fda.gov/consumers/consumerupdates/coronavirus-disease-2019-testing-basics

4) What is the age range for this test? 

This test is authorized for nonprescription home use with self-collected (unobserved) direct anterior nasal (NS) swab specimens from individuals aged 14 years and older or with adult-collected anterior NS samples from individuals aged 2 years or older. 

5) Will this test work if I do not have COVID-19 symptoms?

This test is intended for individuals with or without symptoms or other epidemiological reasons to suspect COVID-19.

**Full FAQ available below under "Downloads" from the manufacturer AconLabs**

Need more information about the FlowFlex COVID-19 Test?

 Download more information here:

• Consumer Insert Sheet
• Healthcare Provider Fact Sheet
• Healthcare Professionals Fact Sheet
• Information Sheet
• Frequently Asked Questions Sheet